A Study Of Milk Consumption In Metabolic Syndrome

Purpose

The primary purpose of this study is to determine the impact of whole-fat dairy consumption on cardiovascular and metabolic risk factors and peripheral vascular function in adults with metabolic syndrome.

Condition

  • Metabolic Syndrome

Eligibility

Eligible Ages
Between 18 Years and 70 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

Presence of 3 of the following risk factors: 1. fasting plasma glucose ≥100 mg/dL (or medical therapy for elevated glucose) 2. HDL-C <40 mg/dL in men or <50 mg/dL in women (or medical therapy for reduced HDL-C) 3. Triglycerides ≥150 mg/dL (or medical therapy for elevated triglycerides) 4. Waist circumference >102 cm for men and >88 cm for women 5. Systolic blood pressure ≥130 mmHg or diastolic blood pressure ≥80 mmHg (or medical therapy for hypertension)

Exclusion Criteria

  1. Cardiovascular disease diagnosis 2. Type 1 or 2 diabetes diagnosis 3. Dairy allergy or lactose intolerance 4. Self-reported high baseline dairy intake (>3 servings per day) 5. >3 hours of physical activity per week 6. Pregnant women 7. Inflammatory bowel disease 8. Chronic steroid use 9. Allergy to metal 10. GLP-1 agonist use 11. Patients on medications related to metabolic syndrome where dose adjustments are planned to be made during the study period.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Primary Purpose
Other
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Full-fat diet first then Low-fat diet
  • Other: Full-fat diet
    The patients will follow a full-fat, isoenergetic diet consisting of 45% carbohydrates, 20% protein, and 35% fat for a duration of three weeks.
  • Other: Low-fat diet
    The patients will follow a low-fat, isoenergetic diet consisting of 45% carbohydrates, 20% protein, and 35% fat for a duration of three weeks.
Experimental
Low-fat diet first then Full-fat diet
  • Other: Full-fat diet
    The patients will follow a full-fat, isoenergetic diet consisting of 45% carbohydrates, 20% protein, and 35% fat for a duration of three weeks.
  • Other: Low-fat diet
    The patients will follow a low-fat, isoenergetic diet consisting of 45% carbohydrates, 20% protein, and 35% fat for a duration of three weeks.

Recruiting Locations

Mayo Clinic in Rochester
Rochester, Minnesota 55905
Contact:
Joshua R. Smith, PhD

More Details

Status
Recruiting
Sponsor
Mayo Clinic

Study Contact

Eric Bruhn
507-266-2690
bruhn.eric@mayo.edu